VOLTAROL TABLETS 50MG

Transcript

1. What Voltarol Tablets are, and what they are
used for

VOLTAROL® Tablets 50 mg
(diclofenac sodium)

Patient Information Leaflet
What you need to know about Voltarol Tablets
Your doctor has decided that you need this medicine to
help treat your condition.
Please read this leaflet carefully before you start to take
your medicine. It contains important information. Keep
the leaflet in a safe place because you may want to read
it again.
If you have any other questions, or if there is something
you don’t understand, please ask your doctor or
pharmacist.
This medicine has been prescribed for you. Never give
it to someone else. It may not be the right medicine for
them even if their symptoms seem to be the same
as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1.
What Voltarol Tablets are, and what they are
used for
2.
Things to consider before you start to take
Voltarol Tablets
3. How to take Voltarol Tablets
4. Possible side effects
5. How to store Voltarol Tablets
6. Further information

2. hings to consider before you start to take
T
Voltarol Tablets
Some people MUST NOT take Voltarol Tablets. Talk to
your doctor if:
• think you may be allergic to diclofenac sodium,
you
aspirin, ibuprofen or any other NSAID, or to any of the
other ingredients of Voltarol Tablets. (These are listed
at the end of the leaflet.) Signs of a hypersensitivity
reaction include swelling of the face and mouth
(angioedema), breathing problems, runny nose, skin
rash or any other allergic type reaction
• have now, or have ever had, a stomach (gastric)
you
or duodenal (peptic) ulcer, or bleeding in the digestive
tract (this can include blood in vomit, bleeding when
emptying bowels, fresh blood in faeces or black,
tarry faeces)
• have had stomach or bowel problems after you
you
have taken other NSAIDs
• you have severe heart, kidney or liver failure
• if you have established heart disease and/or
cerebrovascular disease e.g. if you have had a heart
attack, stroke, mini-stroke (TIA) or blockages to blood

vessels to the heart or brain or an operation to clear
bypass blockages
• if you have or have had problems with your blood
circulation (peripheral arterial disease)
• you are more than six months pregnant.
You should also ask yourself these questions before
taking Voltarol Tablets:
• you suffer from any stomach or bowel disorders
Do
including ulcerative colitis or Crohn’s disease?
• you have kidney or liver problems, or are
Do
you elderly?
• Do you have a condition called porphyria?
• you suffer from any blood or bleeding disorder? If you
Do
do, your doctor may ask you to go for regular check-ups
while you are taking these tablets.
• Have you ever had asthma?
• Are you breast-feeding?
• Do you have angina, blood clots, high blood pressure,
raised cholesterol or raised triglycerides?
• you have heart problems, or have you had a
Do
stroke, or do you think you might be at risk of these
conditions (for example, if you have high blood
pressure, diabetes or high cholesterol or are a smoker)?
• Do you have diabetes?
• Do you smoke?
• you have Lupus (SLE) or any similar condition?
Do
• you have an inherited intolerance to some sugars
Do
such as lactose? (Voltarol Tablets contain a small
amount of lactose.)
If the answer to any of these questions is YES, discuss
your treatment with your doctor or pharmacist because
Voltarol Tablets might not be the right medicine for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell
your doctor or pharmacist if you are taking any of the
following:
• Medicines to treat diabetes
•
Anticoagulants (blood thinning tablets like warfarin)

• Diuretics (water tablets)
• Lithium (used to treat some mental problems)
•
Methotrexate (for some inflammatory diseases and
some cancers)
•
Ciclosporin and tacrolimus (used to treat some
inflammatory diseases and after transplants)
•
Trimethoprim (a medicine used to prevent or treat
urinary tract infections)
• Quinolone antibiotics (for infections)
•
Any other NSAID or COX-2 (cyclo-oxgenase-2)
inhibitor, for example aspirin or ibuprofen
•
Mifepristone (a medicine used to terminate
pregnancy)
•
Cardiac glycosides (for example digoxin), used to treat
heart problems
•
Medicines known as SSRIs used to treat depression
• Oral steroids (an anti-inflammatory drug)
•
Medicines used to treat heart conditions or high blood
pressure, for example beta- blockers or ACE inhibitors
•
Voriconazole (a medicine used to treat
fungal infections)
• Phenytoin (a medicine used to treat seizures)
•
Colestipol/cholestyramine (used to lower cholesterol).
Always tell your doctor or pharmacist about all the
medicines you are taking. This means medicines
you have bought yourself as well as medicines on
prescription from your doctor.
Pregnancy
• you pregnant or planning to become pregnant?
Are
Although not common, abnormalities have been
reported in babies whose mothers have taken NSAIDs
during pregnancy. You should not take Voltarol Tablets
during the last 3 months of pregnancy as it may affect
the baby’s circulation.
• you trying for a baby? Taking Voltarol Tablets may
Are
make it more difficult to conceive. You should talk to
your doctor if you are planning to become pregnant,
or if you have problems getting pregnant.

Will there be any problems with driving or
using machinery?
Very occasionally people have reported that
Voltarol Tablets have made them feel dizzy, tired or
sleepy. Problems with eyesight have also been reported.
If you are affected in this way, you should not drive or
operate machinery.
Other special warnings
•
You should take the lowest dose of Voltarol for the
shortest possible time, particularly if you are
underweight or elderly.
•
There is a small increased risk of heart attack or
stroke when you are taking any medicine like Voltarol.
The risk is higher if you are taking high doses for a
long time. Always follow the doctor’s instructions on
how much to take and how long to take it for.
•
Whilst you are taking these medicines your doctor
may want to give you a check-up from time to time.
• you have a history of stomach problems when you
If
are taking NSAIDs, particularly if you are elderly, you
must tell your doctor straight away if you notice any
unusual symptoms.
•
Because it is an anti-inflammatory medicine, Voltarol
may reduce the symptoms of infection, for example,
headache and high temperature. If you feel unwell and
need to see a doctor, remember to tell him or her that
you are taking Voltarol.
•
The 50 mg tablets are not suitable for children aged
under 12.

3. How to take Voltarol Tablets
The doctor will tell you how many Voltarol Tablets to take
and when to take them. Always follow his/her instructions
carefully. The dose will be on the pharmacist’s label.
Check the label carefully. If you are not sure, ask your
doctor or pharmacist. Keep taking your tablets for as long

as you have been told, unless you have any problems.
In that case, check with your doctor.
Take the tablets before or with food.
Swallow the tablets whole with a drink of water. Do not
crush or chew the tablets.
The usual doses are:
Adults
75 mg to 150 mg daily divided into two or three doses.
The number of tablets which you take will depend on the
strength the doctor has given you.
Elderly
Your doctor may advise you to take a dose that is lower
than the usual adult dose if you are elderly. Your doctor
may also want to check closely that the Voltarol Tablets
are not affecting your stomach.
Children
Not recommended for children.
The doctor may also prescribe another drug to protect the
stomach to be taken at the same time, particularly if you
have had stomach problems before, or if you are elderly, or
taking certain other drugs as well.
What if you forget to take a dose?
If you forget to take a dose, take one as soon as you
remember. If it is nearly time for your next dose, though,
just take the next dose and forget about the one you
missed. Do not double up on the next dose to make up
for the one missed. Do not take more than 150 mg
(three 50 mg tablets) in 24 hours.
What if you take too many tablets?
If you, or anyone else, accidentally takes too much, tell
your doctor or your nearest hospital casualty department.
Take your medicine pack with you so that people can see
what you have taken.

4. Possible side effects

Voltarol Tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects.

Side effects may be minimised by using the lowest
effective dose for the shortest duration necessary.
Some side effects can be serious
Stop taking Voltarol Tablets and tell your doctor straight
away if you notice:
•
Stomach pain, indigestion, heartburn, wind, nausea
(feeling sick) or vomiting (being sick)
•
Any sign of bleeding in the stomach or intestine, for
example, when emptying your bowels, blood in vomit
or black, tarry faeces
•
Allergic reactions which can include skin rash,
itching, bruising, painful red areas, peeling
or blistering
•
Wheezing or shortness of breath (bronchospasm)
•
Swollen face, lips, hands or fingers
•
Yellowing of your skin or the whites of your eyes
•
Persistent sore throat or high temperature
• unexpected change in the amount of urine
An
produced and/or its appearance.
If you notice that you are bruising more easily
than usual or have frequent sore throats or infections, tell
your doctor.
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and
10 in every 100 patients):
•
Stomach pain, heartburn, nausea, vomiting,
diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.
Rare side effects (These may affect between
1 in every 1000 to 1 in every 10,000 patients):
•
Stomach ulcers or bleeding (there have been very rare
reported cases resulting in death, particularly in the
elderly)
•
Gastritis (inflammation, irritation or swelling of the
stomach lining)

•
Vomiting blood
•
Diarrhoea with blood in it or bleeding from the back
passage
•
Black, tarry faeces or stools
• Drowsiness, tiredness
•
Hypotension (low blood pressure, symptoms of which
may include faintness, giddiness or light headedness)
• Skin rash and itching
•
Fluid retention, symptoms of which include
swollen ankles
•
Liver function disorders, including hepatitis and
jaundice.
Very rare side effects (These may affect less than 1 in
every 10,000 patients):
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, visual
disturbances such as blurred vision, blurred or double vision,
hearing loss or impairment, tinnitus (ringing in the ears),
sleeplessness, nightmares, mood changes, depression,
anxiety, mental disorders, disorientation and loss of memory,
fits, headaches together with a dislike of bright lights, fever
and a stiff neck, disturbances in sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers,
inflammation of the inside of the mouth or lips, taste
changes, lower gut disorders (including inflammation of the
colon, or worsening of ulcerative colitis or Crohn’s disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain,
hypertension (high blood pressure), inflammation of blood
vessels (vasculitis), inflammation of the lung (pneumonitis),
heart disorders, including congestive heart failure or heart
attack, blood disorders (including anaemia).
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure,
presence of blood or protein in the urine.
1807233 GB (193)

Effects on skin or hair:
Serious skin rashes including Stevens-Johnson syndrome
and Lyell’s syndrome and other skin rashes which may be
made worse by exposure to sunlight.
Hair loss.
Other side effects that have also been reported include:
Inflammation of the pancreas, impotence. Facial swelling,
inflammation of the lining of the brain (meningitis),
stroke, throat disorders, confusion, hallucinations,
malaise (general feeling of discomfort), inflammation of
the nerves of the eye.
Do not be alarmed by this list – most people take
Voltarol Tablets without any problems.
If any of the symptoms become troublesome, or if you
notice anything else not mentioned here, please go and
see your doctor. He/she may want to give you a different
medicine.

If you would like any more information, or would like the
leaflet in a different format, please contact Medical
Information at
Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.

Store in a dry place, below 30°C. Keep the tablets in
their original pack.
Do not take Voltarol Tablets after the expiry date which is
printed on the outside of the pack.
If your doctor tells you to stop taking the tablets, please
take any unused tablets back to your pharmacist to be
destroyed. Do not throw them away with your normal
household water or waste. This will help to protect the
environment.

The tablets contain 50 mg of the active ingredient,
diclofenac sodium. The tablets are enteric-coated. This
special coating prevents absorption of diclofenac sodium
in the stomach, reducing the risk of stomach irritation.
It is absorbed when it reaches the intestine.

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